INSERM U1153, Statistic and Epidemiologic Research Centre Sorbonne Paris Cité (CRESS), ECSTRA Team, Université Diderot - Paris 7, USPC, Paris, France.
Department of Neurosurgery, Lariboisière Hospital, 75010, Paris, France.
J Neurooncol. 2020 Mar;147(1):159-169. doi: 10.1007/s11060-020-03410-1. Epub 2020 Jan 23.
Carmustine wafers (CW) are approved to treat newly or recurrent high-grade gliomas (HGG). Widespread use has been limited regarding some doubtful uncertainties about their efficacy, related increased risk of infection and expensive cost.
To describe the epidemiology of CW implantation, search for related complications, long-term survival and associated prognostic factors.
We processed the French medico-administrative national database to retrieve appropriate cases operated between 2010 and 2018. A survival analysis was conducted.
We identified 1659 patients treated in 39 institutions. Median age at CW implantation was 61 years and there was an over-representation of male (63.5%). 491 patients (29.6%) had previous diagnosis of glioma. Time between the first surgery and CW implantation was 0.9 years, IQR[0.6, 1.6]. The frontal lobe was the most frequently involved 29%. 131 patients (7.9%) had to be re operated on for a complication of which 121 for surgical site infection. At one year, 514 patients (31%) had died. Median overall survival (OS) was 1.4 years, CI [1.3, 1.5]. OS at 1 and 2 year was 66%, CI [63.7, 68.5], 32.3%, CI [29.9, 35]. In the adjusted Cox regression, male gender & age at CW implantation were established as independent factors of OS in all three groups. Patients with recurrent HGG have a significant worse prognosis (HR = 0.71, CI [0.62, 0.80] p < 0.001). A post-operative diagnosis of infection or intracranial bleeding eventually leading to a redo surgery was not associated with a decrease OS.
Over the past 9 years, there is a significant decrease utilisation of CW in France. OS after CW implantation is significantly variable as influenced by many factors such as age, gender or recurrent disease but not by post-operative complications. Compare to previous results, CW may increase the OS and this effect seems more pronounced when adjuvant RT/TMZ is given.
卡莫司汀植入剂(CW)获批用于治疗新发或复发性高级别胶质瘤(HGG)。由于对其疗效、相关感染风险增加和昂贵成本存在一些不确定因素,其广泛应用受到限制。
描述 CW 植入的流行病学情况,寻找相关并发症、长期生存和相关预后因素。
我们处理了法国医疗管理国家数据库,以检索 2010 年至 2018 年期间在 39 家机构接受治疗的合适病例。进行了生存分析。
我们确定了 1659 名接受治疗的患者,这些患者来自 39 家机构。CW 植入时的中位年龄为 61 岁,男性(63.5%)比例偏高。491 名(29.6%)患者曾有胶质瘤诊断史。首次手术与 CW 植入之间的时间为 0.9 年,IQR[0.6, 1.6]。额叶最常受累,占 29%。131 名(7.9%)患者因并发症需再次手术,其中 121 名因手术部位感染。1 年后,514 名(31%)患者死亡。中位总生存期(OS)为 1.4 年,CI [1.3, 1.5]。1 年和 2 年的 OS 分别为 66%,CI [63.7, 68.5],32.3%,CI [29.9, 35]。在调整后的 Cox 回归中,男性和 CW 植入时的年龄被确定为所有三组患者 OS 的独立因素。复发性 HGG 患者的预后显著更差(HR=0.71,CI [0.62, 0.80],p<0.001)。术后诊断为感染或颅内出血,最终导致再次手术,与 OS 降低无关。
在过去 9 年中,法国 CW 的应用显著减少。CW 植入后的 OS 变化显著,受多种因素影响,如年龄、性别或复发性疾病,但与术后并发症无关。与之前的结果相比,CW 可能会提高 OS,且当辅助 RT/TMZ 治疗时,这种效果更为显著。